Phase 3
Completed N=424
A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01059812 ↗Enrolled (actual)
424
Serious AEs
8.3%
Results posted
Nov 2015
Primary outcomePrimary: Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment — -1.38; -1.42 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment |
-1.38; -1.42 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 |
7.6; 7.9 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
956; 952 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
111; 155 | — |
| SECONDARY Change in Body Weight |
1.1; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female at least 18 years of age (at least 20 years for Japan)
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- Body mass index (BMI) maximum 35.0 kg/m^2
Exclusion Criteria
- Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1
- Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 3 months prior to Visit 1
- Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
Data sourced from ClinicalTrials.gov (NCT01059812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.